AQUABPLUS, B2, HF 2500 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED INITIALLY CONTACTED FRESENIUS WHEN THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR ¿F-04-50-04 SUPPLY FAILURE TEST, PUMP P1 DEFECTIVE.¿ UPON TROUBLESHOOTING, THERMAL DAMAGE WAS IDENTIFIED ON THE TOP TWO WIRES OF THE THERMAL OVERLOAD RELAY AND TWO FUSES (25A 600V AC) WITHIN THE MAIN POWER BOX (NOT A FRESENIUS PRODUCT) WERE FOUND TO BE BLOWN. THE BIOMED DESCRIBED THE INSULATION ON THE TOP TWO WIRES OF THE THERMAL OVERLOAD RELAY AS MELTED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE SYSTEM IS SECURED INTO ITS OWN BREAKER. THE SUSPECTED CAUSE FOR THE FAILURE IS THE NUMEROUS POWER OUTAGES THAT OCCUR IN THE AREA. ALTHOUGH THE BIOMED STATED THERE WERE NO RECENT LOCAL POWER GRID ISSUES, IT WAS CONFIRMED THERE WERE ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE ISSUE WAS RESOLVED BY REPLACING THE POWER SWITCH AND BLOWN FUSES WITHIN THE MAIN POWER BOX ON THE WALL. AT THE TIME OF FOLLOW-UP, REPLACEMENT WIRING WAS BACKORDERED. THE TOP TWO WIRES WERE COVERED WITH ELECTRICAL TAPE UNTIL THEY COULD BE REPLACED. THE SYSTEM WAS RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AS TREATMENT HAD NOT YET BEGUN FOR THE DAY. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PHOTOGRAPHS OR SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETAINED FOR REVIEW BY THE MANUFACTURER.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED EVENT WAS CONFIRMED BY THE MANUFACTURER USING THE INFORMATION PROVIDED BY THE CUSTOMER. THE CAUSE FOR THE IDENTIFIED THERMAL DAMAGE WAS LIKELY A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS WHICH OVERHEATED AND DAMAGED THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH. DUE TO THE BAD ELECTRICAL CONTACT, A MAINS LINE COULD BE MISSING AND THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH (DEPENDING ON THE OPERATION MODE) IS LOADED UNBALANCED AND COULD TRIP. AS A CONSEQUENCE THE DEVICE OPERATION WAS INTERRUPTED AND THE ERROR CODES WERE TRIGGERED. A CONTRIBUTING FACTOR FOR A TRIPPING MOTOR PROTECTION SWITCH OR THERMAL OVERLOAD RELAY COULD BE ALSO POWER ISSUES (LINE FLUCTUATIONS/BLOWN FUSE) WHICH DO CAUSE HIGHER CURRENTS. THESE CONSTANT HIGH CURRENTS DO ALSO CAUSE A TRIGGERED MOTOR PROTECTION SWITCH OR THERMAL OVERLOAD RELAY. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. A NEW WIRING DESIGN WAS RELEASED. ACCORDING TO THE INTAKE INFORMATION THE ISSUE WAS RESOLVED BY REPLACING THE MOTOR PROTECTION SWITCH. IT IS RECOMMENDED TO CHECK AND REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO AVOID ADDITIONAL FAILURES.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED INITIALLY CONTACTED FRESENIUS WHEN THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR ¿F-04-50-04 SUPPLY FAILURE TEST, PUMP P1 DEFECTIVE.¿ UPON TROUBLESHOOTING, THERMAL DAMAGE WAS IDENTIFIED ON THE TOP TWO WIRES OF THE MOTOR PROTECTION SWITCH (MPS) AND TWO FUSES (25A 600V AC) WITHIN THE MAIN POWER BOX (NOT A FRESENIUS PRODUCT) WERE FOUND TO BE BLOWN. THE BIOMED DESCRIBED THE INSULATION ON THE TOP TWO WIRES OF THE MPS AS MELTED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE SYSTEM IS SECURED INTO ITS OWN BREAKER. THE SUSPECTED CAUSE FOR THE FAILURE IS THE NUMEROUS POWER OUTAGES THAT OCCUR IN THE AREA. ALTHOUGH THE BIOMED STATED THERE WERE NO RECENT LOCAL POWER GRID ISSUES, IT WAS CONFIRMED THERE WERE ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE ISSUE WAS RESOLVED BY REPLACING THE MPS AND BLOWN FUSES WITHIN THE MAIN POWER BOX ON THE WALL. REPLACEMENT WIRING WAS BACKORDERED AT THE TIME OF FOLLOW-UP. THE TOP TWO WIRES WERE COVERED WITH ELECTRICAL TAPE UNTIL THEY COULD BE REPLACED. THE SYSTEM WAS RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AS TREATMENT HAD NOT YET BEGUN FOR THE DAY. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PHOTOGRAPHS OR SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETAINED FOR REVIEW BY THE MANUFACTURER.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED INITIALLY CONTACTED FRESENIUS WHEN THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR ¿F-04-50-04 SUPPLY FAILURE TEST, PUMP P1 DEFECTIVE.¿ UPON TROUBLESHOOTING, THERMAL DAMAGE WAS IDENTIFIED ON THE TOP TWO WIRES OF THE MOTOR PROTECTION SWITCH (MPS) AND TWO FUSES (25A 600V AC) WITHIN THE MAIN POWER BOX (NOT A FRESENIUS PRODUCT) WERE FOUND TO BE BLOWN. THE BIOMED DESCRIBED THE INSULATION ON THE TOP TWO WIRES OF THE MPS AS MELTED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE SYSTEM IS SECURED INTO ITS OWN BREAKER. THE SUSPECTED CAUSE FOR THE FAILURE IS THE NUMEROUS POWER OUTAGES THAT OCCUR IN THE AREA. ALTHOUGH THE BIOMED STATED THERE WERE NO RECENT LOCAL POWER GRID ISSUES, IT WAS CONFIRMED THERE WERE ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE ISSUE WAS RESOLVED BY REPLACING THE MPS AND BLOWN FUSES WITHIN THE MAIN POWER BOX ON THE WALL. REPLACEMENT WIRING WAS BACKORDERED AT THE TIME OF FOLLOW-UP. THE TOP TWO WIRES WERE COVERED WITH ELECTRICAL TAPE UNTIL THEY COULD BE REPLACED. THE SYSTEM WAS RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AS TREATMENT HAD NOT YET BEGUN FOR THE DAY. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. NO PHOTOGRAPHS OR SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETAINED FOR REVIEW BY THE MANUFACTURER.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 (EVENT DESCRIPTION) THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.